Autologous Bone Marrow Stem Cell Therapy for Autism

Autistic Disorder Clinical Trial

Official title:

Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627131
• Other study ID #: TBG 003
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2015
• Last updated: December 8, 2015
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Vinmec International Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Hanoi Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

Description:

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 16 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for autistic disorder

Exclusion Criteria:

• Epilepsy

• Hydrocephalus with ventricular drain

• Coagulation disorders

• Allergy to anesthetic agents

• Severe health conditions such as cancer, failure of heart, lung, liver or kidney

• Active infections

• Severe psychiatric disorders

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Biological:
• Autologous Bone Marrow Mononuclear Cells
Transplantation of Autologous Bone Marrow Mononuclear Cells

Locations

Country	Name	City	State
Vietnam	Vinmec International Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec International Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

Sharma A, Gokulchandran N, Sane H, Nagrajan A, Paranjape A, Kulkarni P, Shetty A, Mishra P, Kali M, Biju H, Badhe P. Autologous bone marrow mononuclear cell therapy for autism: an open label proof of concept study. Stem Cells Int. 2013;2013:623875. doi: 10.1155/2013/623875. Epub 2013 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Score of Childhood Autism Rating Scale (CARS)	CARS	3 months and 6 months after transplantation	No
Primary	Number of adverse events	Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits	Through study completion, an average of 6 months	Yes